FDA recall, , Low risk
Cipla Diclofenac Sodium Topical Gel 1%
Diclofenac Sodium Topical Gel, 1% failed pH specifications.
Summary by Recall Canary from the FDA notice
What happened
Cipla USA, Inc., of Warren, New Jersey, recalled Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), because it failed pH specifications. The product was manufactured by DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215, and distributed nationwide in the USA. The recall began on December 22, 2025, and was added to the FDA's Enforcement Report on January 20, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC matches.
An NDC (National Drug Code) is usually printed on the drug's label.
Diclofenac Sodium Topical Gel, 1%
- NDC
- 76282-103-39
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Cipla USA, Inc.Warren, New Jersey
- Hazard
- Quality testing problem
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98193
- Recall number
- D-0291-2026
- Quantity recalled
- 92,376 tubes
All recalls from Cipla USA, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
